03-22961. Technical Electronic Product Radiation Safety Standards Committee; Notice of Meeting

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public.

Name of Committee: Technical Electronic Product Radiation Safety Standards Committee.

General Function of the Committee: To provide advice on technical feasibility, reasonableness, and practicality of performance standards for electronic products to control the emission of radiation under 21 U.S.C. 360kk(f).

Date and Time: The meeting will be held on October 1, 2003, from 8:30 a.m. to 5 p.m.

Location: Hilton Washington DC North/Gaithersburg, Salons A and B, 620 Perry Pkwy., Gaithersburg, MD.

Contact Person: Richard Kaczmarek, Center for Devices and Radiological Health (HFZ-240), Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850, 301-594-0865, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 12399. Please call the Information Line for up-to-date information on this meeting.

Agenda: The committee will hear an informal review of ongoing activities associated with electronic products.

Following the overview, FDA will discuss proposed amendments to the U.S. performance standard for sunlamp products (21 CFR 1040.20) and certain initiatives of international standards organizations concerning sunlamp products.

In the afternoon, there will be a presentation regarding proposed amendments to the diagnostic x-ray system performance standard (21 CFR 1020.30). Following this, the final topic will be public health considerations of x-ray security screening systems and the development of policies for safe use of these systems.

Background information on the discussion topics will be posted under the Technical Electronic Product Radiation Safety Standards Committee (TEPRSSC) Docket site at http://www.fda.gov/​ohrms/​dockets/​ac/​acmenu.htm. (Click on the year 2003 and scroll down to TEPRSSC.)

Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person by September 19, 2003. Oral presentations from the public will be scheduled between approximately 10:45 a.m. and 11:30 a.m., and between 3 p.m. and 3:45 p.m. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before September 19, 2003, and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation.

Persons attending FDA's advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets.

FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Shirley Meeks, Conference Management Staff, at 301-594-1283, ext. 105, at least 7 days in advance of the meeting.

Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).

Dated: September 3, 2003.

Peter J. Pitts,

Associate Commissioner for External Relations.